Virological measures and factors associated with outcomes, and missing outcome data in HIV clinical trials: a methodological study

BackgroundTo evaluate the definition of HIV virological outcomes in the literature and factors associated with outcomes and missing outcome data.MethodsWe conducted a methodological review of HIV RCTs using a search (2009–2019) of PubMed, Embase and the Cochrane Central Register of Controlled Trials.Only full-text, peer-reviewed, randomised controlled trials (RCTs) that measured virological outcomes in people living with HIV, and published in English were included.We extracted study details and outcomes. We used logistic regression to identify factors associated with a viral threshold ≤50 copies/mL and linear regression to identify factors associated with missing outcome data.ResultsOur search yielded 5847 articles; 180 were included. A virological outcome was the primary outcome in 73.5% of studies. 89 studies (49.4%) used virological success. The remaining used change in viral load (VL) (33 studies, 18.3%); virological failure (59 studies, 32.8%); or virological rebound (9 studies, 5.0%). 96 studies (53.3%) set the threshold at ≤50 copies/mL; and 33.1% used multiple measures.Compared with government and privately funded studies, RCTs with industry funding (adjusted OR 6.39; 95% CI 2.15 to 19.00; p<0.01) were significantly associated with higher odds of using a VL threshold of ≤50 copies/mL. Publication year, intervention type, income level and number of patients were not associated with a threshold of ≤50 copies/mL. Trials with pharmacological interventions had less missing data (β=−11.04; 95% CI −20.02 to −1.87; p=0.02).DiscussionCountry source of funding was associated with VL threshold choice and studies with pharmacological interventions had less missing data, which may in part explain heterogeneous virological outcomes across studies. Multiple measures of VL were not associated with missing data. The development of formal guidelines on virological outcome reporting in RCTs is needed.

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Prevention of recurrent miscarriage in women with antiphospholipid syndrome: A systematic review and network meta-analysis

Lupus ◽

10.1177/0961203320967097 ◽

2020 ◽

Vol 30 (1) ◽

pp. 70-79

Author(s):

Ziyi Yang ◽

Xiangli Shen ◽

Chuqing Zhou ◽

Min Wang ◽

Yi Liu ◽

...

Keyword(s):

Preterm Birth ◽

Antiphospholipid Syndrome ◽

Live Birth ◽

Birth Rate ◽

Recurrent Miscarriage ◽

Live Birth Rate ◽

Controlled Trials ◽

Cochrane Central Register ◽

Pharmacological Interventions ◽

Significant Difference

Objectives To compare and rank currently available pharmacological interventions for the prevention of recurrent miscarriage (RM) in women with antiphospholipid syndrome (APS). Methods A search was performed using PubMed, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, CNKI, ClinicalTrials.gov, and the UK National Research Register on December 15, 2019. Studies comparing any types of active interventions with placebo/inactive control or another active intervention for the prevention of RM in patients with APS were considered for inclusion. The primary outcomes were efficacy (measured by live birth rate) and acceptability (measured by all-cause discontinuation); secondary outcomes were birthweight, preterm birth, preeclampsia, and intrauterine growth retardation. The protocol of this study was registered with Open Science Framework (DOI: 10.17605/OSF.IO/B9T4E). Results In total, 54 randomized controlled trials (RCTs) comprising 4,957 participants were included. Low-molecular-weight heparin (LMWH) alone, aspirin plus LMWH or unfractionated heparin (UFH), aspirin plus LMWH plus intravenous immunoglobulin (IVIG), aspirin plus LMWH plus IVIG plus prednisone were found to be effective pharmacological interventions for increasing live birth rate (ORs ranging between 2.88 to 11.24). In terms of acceptability, no significant difference was found between treatments. In terms of adverse perinatal outcomes, aspirin alone was associated with a higher risk of preterm birth than aspirin plus LMWH (OR 3.92, 95% CI 1.16 to 16.44) and with lower birthweight than LMWH (SMD −808.76, 95% CI −1596.54 to −5.07). Conclusions Our findings support the use of low-dose aspirin plus heparin as the first-line treatment for prevention of RM in women with APS, and support the efficacy of hydroxychloroquine, IVIG, and prednisone when added to current treatment regimens. More large-scale, high-quality RCTs are needed to confirm these findings, and new pharmacological options should be further evaluated.

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Use of wearable biometric monitoring devices to measure outcomes in randomized clinical trials: a methodological systematic review

BMC Medicine ◽

10.1186/s12916-020-01773-w ◽

2020 ◽

Vol 18 (1) ◽

Author(s):

Carolina Graña Possamai ◽

Philippe Ravaud ◽

Lina Ghosn ◽

Viet-Thi Tran

Keyword(s):

Systematic Review ◽

Randomized Clinical Trials ◽

Outcome Data ◽

Pharmacological Intervention ◽

Controlled Trials ◽

Cochrane Central Register ◽

Outcome Reporting Bias ◽

Hand Search ◽

Clinical Trial Registries ◽

Monitoring Devices

Abstract Background Wearable biometric monitoring devices (BMDs) have the potential to transform the conduct of randomized controlled trials (RCTs) by shifting the collection of outcome data from single measurements at predefined time points to dense continuous measurements. Methods Methodological systematic review to understand how recent RCTs used BMDs to measure outcomes and to describe the reporting of these RCTs. Electronic search was performed in the Cochrane Central Register of Controlled Trials, PubMed, and EMBASE and completed a page-by-page hand search in five leading medical journals between January 1, 2018, and December 31, 2018. Three reviewers independently extracted all primary and secondary outcomes collected using BMDs, and assessed (1) the definitions used to summarize BMD outcome data; (2) whether the validity, reliability, and responsiveness of sensors was reported; (3) the discrepancy with outcomes prespecified in public clinical trial registries; and (4) the methods used to manage missing and incomplete BMD outcome data. Results Of the 4562 records screened, 75 RCTs were eligible. Among them, 24% tested a pharmacological intervention and 57% used an inertial measurement sensor to measure physical activity. Included trials involved 464 outcomes (average of 6 [SD = 8] outcomes per trial). In total, 35 trials used a BMD to measure a primary outcome. Several issues affected the value and transparency of trials using BMDs to measure outcomes. First, the definition of outcomes used in the trials was highly heterogeneous (e.g., 21 diabetes trials had 266 outcomes and 153 had different unique definitions to measure diabetes control), which limited the combination and comparison of results. Second, information on the validity, reliability, and responsiveness of sensors used was lacking in 74% of trials. Third, half (53%) of the outcomes measured with BMDs had not been prespecified, with a high risk of outcome reporting bias. Finally, reporting on the management of incomplete outcome data (e.g., due to suboptimal compliance with the BMD) was absent in 68% of RCTs. Conclusions Use of BMDs to measure outcomes is becoming the norm rather than the exception in many fields. Yet, trialists need to account for several methodological issues when specifying and conducting RCTs using these novel tools.

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Evidence map of pancreatic surgery: protocol for a living systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2019-032353 ◽

2019 ◽

Vol 9 (9) ◽

pp. e032353

Author(s):

Pascal Probst ◽

Felix J Hüttner ◽

Ömer Meydan ◽

Eva Kalkum ◽

Rüdiger Kretschmer ◽

...

Keyword(s):

Pancreatic Surgery ◽

Clinical Decision Making ◽

Meta Analysis ◽

Clinical Decision ◽

Outcome Data ◽

Primary Data ◽

Future Research ◽

Controlled Trials ◽

Cochrane Central Register ◽

Evidence Map

IntroductionPancreatic surgery is a large and complex field of research. Several evidence gaps exist for specific diseases or surgical procedures. An overview on existing knowledge is needed to plan and prioritise future research. The aim of this project is to create a systematic and living evidence map of pancreatic surgery.Methods and analysisA systematic literature search in MEDLINE (via PubMed), Web of Science and Cochrane Central Register of Controlled Trials will be performed searching for all randomised controlled trials (RCT) and systematic reviews (SR) on pancreatic surgery. RCT and SR will be grouped in research topics. Baseline and outcome data from RCT will be extracted, presented and effect sizes meta-analysed. Data from SR will be used to identify evidence gaps. A freely accessible web-based evidence map in the format of a mind map will be created. The evidence map and meta-analyses will be updated periodically.DisseminationAfter completion of the project, a permanently updated evidence map of pancreatic surgery will be available to patients, physicians, researchers and funding bodies viawww.evidencemap.surgery. Its use will allow clinical decision-making based on primary data and prioritisation of future research endeavours.PROSPERO registration numberCRD42019133444.

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Pharmacological interventions for preventing rocuronium-induced pain responses and rocuronium-induced withdrawal responses: a systematic review and network meta-analysis

10.22514/sv.2020.16.0108 ◽

2020 ◽

Keyword(s):

Systematic Review ◽

General Anesthesia ◽

Meta Analysis ◽

Controlled Trials ◽

Pain Response ◽

Cochrane Central Register ◽

Pharmacological Interventions ◽

Study Objective ◽

Central Register ◽

Withdrawal Response

Study objective: Rocuronium is widely used during the induction of general anesthesia. However, it is associated with rocuronium-induced pain response, which can appear as a rocuronium-induced withdrawal response. The purpose of this study was to compare the effectiveness of pharmacological interventions in preventing rocuronium-induced pain response and rocuronium-induced withdrawal response using a network meta-analysis. Design: Systematic review and network meta-analysis (NMA) of RCTs. Setting: Pharmacological interventions to prevent rocuronium-induced pain response and rocuronium-induced pain response and rocuronium-induced withdrawal. Data sources: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Google Scholar were systematically searched from its inception until Mar 2020. Methods: We searched multiple databases and extracted randomized controlled trials that compared two or more pharmacological interventions to prevent rocuronium-induced pain response and rocuronium-induced withdrawal response in adult patients who received rocuronium injections for general anesthesia. We conducted network meta-analysis and used surface under the cumulative ranking curve values and rankograms to present the hierarchy of the pharmacological interventions evaluated. Results: In total, 43 studies (5,291 patients) were included in this network meta-analysis and 31 pharmacological interventions were evaluated. The rankogram and cumulative ranking plot showed that oxycodone followed by a combination of lidocaine and sodium bicarbonate (NaHCO3), esmolol, alfentanil, and rocuronium mixed with NaHCO3 had the lowest frequency of rocuronium-induced withdrawal response. In terms of rocuronium-induced pain response, NaHCO3 mixed with rocuronium showed the lowest frequency, followed by a combination of lidocaine and NaHCO3, a combination of lidocaine and nitrous oxide, rocuronium mixed with lidocaine, and lidocaine. Conclusions: Lidocaine administration has been shown to reduce the incidence of rocuronium-induced pain response regardless of the method of injection or drug combination. The combination of lidocaine and NaHCO3 or mixing NaHCO3with rocuronium was effective at reducing rocuronium-induced withdrawal response. In particular, oxycodone was shown to be more effective than the other opioids evaluated and esmolol was also found to be effective at reducing rocuronium-induced withdrawal response.

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Interventions for Breathlessness in Patients With Advanced Cancer

10.23970/ahrqepccer232 ◽

2020 ◽

Author(s):

Sydney M. Dy ◽

Arjun Gupta ◽

Julie M. Waldfogel ◽

Ritu Sharma ◽

Allen Zhang ◽

...

Keyword(s):

Cohort Studies ◽

Exercise Capacity ◽

Advanced Cancer ◽

Controlled Trials ◽

Cochrane Central Register ◽

Pharmacological Interventions ◽

Cancer Data ◽

Routes Of Administration ◽

Retrospective Cohort Studies ◽

Meta Analyses

Objectives. To assess benefits and harms of nonpharmacological and pharmacological interventions for breathlessness in adults with advanced cancer. Data sources. We searched PubMed®, Embase®, CINAHL®, ISI Web of Science, and the Cochrane Central Register of Controlled Trials through early May 2020. Review methods. We included randomized controlled trials (RCTs) and observational studies with a comparison group evaluating benefits and/or harms, and cohort studies reporting harms. Two reviewers independently screened search results, serially abstracted data, assessed risk of bias, and graded strength of evidence (SOE) for key outcomes: breathlessness, anxiety, health-related quality of life, and exercise capacity. We performed meta-analyses when possible and calculated standardized mean differences (SMDs). Results. We included 48 RCTs and 2 retrospective cohort studies (4,029 patients). The most commonly reported cancer types were lung cancer and mesothelioma. The baseline level of breathlessness varied in severity. Several nonpharmacological interventions were effective for breathlessness, including fans (SMD -2.09 [95% confidence interval (CI) -3.81 to -0.37]) (SOE: moderate), bilevel ventilation (estimated slope difference -0.58 [95% CI -0.92 to -0.23]), acupressure/reflexology, and multicomponent nonpharmacological interventions (behavioral/psychoeducational combined with activity/rehabilitation and integrative medicine). For pharmacological interventions, opioids were not more effective than placebo (SOE: moderate) for improving breathlessness (SMD -0.14 [95% CI -0.47 to 0.18]) or exercise capacity (SOE: moderate); most studies were of exertional breathlessness. Different doses or routes of administration of opioids did not differ in effectiveness for breathlessness (SOE: low). Anxiolytics were not more effective than placebo for breathlessness (SOE: low). Evidence for other pharmacological interventions was limited. Opioids, bilevel ventilation, and activity/rehabilitation interventions had some harms compared to usual care. Conclusions. Some nonpharmacological interventions, including fans, acupressure/reflexology, multicomponent interventions, and bilevel ventilation, were effective for breathlessness in advanced cancer. Evidence did not support opioids or other pharmacological interventions within the limits of the identified studies. More research is needed on when the benefits of opioids may exceed harms for broader, longer term outcomes related to breathlessness in this population.

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Pharmacological and non-pharmacological interventions for non-respiratory sleep disturbance in children with neurodisabilities: a systematic review

Health Technology Assessment ◽

10.3310/hta22600 ◽

2018 ◽

Vol 22 (60) ◽

pp. 1-296 ◽

Cited By ~ 7

Author(s):

Bryony Beresford ◽

Catriona McDaid ◽

Adwoa Parker ◽

Arabella Scantlebury ◽

Gemma Spiers ◽

...

Keyword(s):

Sleep Disturbance ◽

Clinical Effectiveness ◽

Sleep Time ◽

Risk Of Bias ◽

Controlled Trials ◽

Cochrane Central Register ◽

Pharmacological Interventions ◽

Statistical Heterogeneity ◽

Before And After ◽

Randomised Controlled

BackgroundThere is uncertainty about the most appropriate ways to manage non-respiratory sleep disturbances in children with neurodisabilities (NDs).ObjectiveTo assess the clinical effectiveness and safety of NHS-relevant pharmacological and non-pharmacological interventions to manage sleep disturbance in children and young people with NDs, who have non-respiratory sleep disturbance.Data sourcesSixteen databases, including The Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE, were searched up to February 2017, and grey literature searches and hand-searches were conducted.Review methodsFor pharmacological interventions, only randomised controlled trials (RCTs) were included. For non-pharmacological interventions, RCTs, non-randomised controlled studies and before-and-after studies were included. Data were extracted and quality assessed by two researchers. Meta-analysis and narrative synthesis were undertaken. Data on parents’ and children’s experiences of receiving a sleep disturbance intervention were collated into themes and reported narratively.ResultsThirty-nine studies were included. Sample sizes ranged from 5 to 244 participants. Thirteen RCTs evaluated oral melatonin. Twenty-six studies (12 RCTs and 14 before-and-after studies) evaluated non-pharmacological interventions, including comprehensive parent-directed tailored (n = 9) and non-tailored (n = 8) interventions, non-comprehensive parent-directed interventions (n = 2) and other non-pharmacological interventions (n = 7). All but one study were reported as having a high or unclear risk of bias, and studies were generally poorly reported. There was a statistically significant increase in diary-reported total sleep time (TST), which was the most commonly reported outcome for melatonin compared with placebo [pooled mean difference 29.6 minutes, 95% confidence interval (CI) 6.9 to 52.4 minutes;p = 0.01]; however, statistical heterogeneity was extremely high (97%). For the single melatonin study that was rated as having a low risk of bias, the mean increase in TST was 13.2 minutes and the lower CI included the possibility of reduced sleep time (95% CI –13.3 to 39.7 minutes). There was mixed evidence about the clinical effectiveness of the non-pharmacological interventions. Sixteen studies included interventions that investigated the feasibility, acceptability and/or parent or clinician views of sleep disturbance interventions. The majority of these studies reported the ‘family experience’ of non-pharmacological interventions.LimitationsPlanned subgroup analysis was possible in only a small number of melatonin trials.ConclusionsThere is some evidence of benefit for melatonin compared with placebo, but the degree of benefit is uncertain. There are various types of non-pharmacological interventions for managing sleep disturbance; however, clinical and methodological heterogeneity, few RCTs, a lack of standardised outcome measures and risk of bias means that it is not possible to draw conclusions with regard to their effectiveness. Future work should include the development of a core outcome, further evaluation of the clinical effectiveness and cost-effectiveness of pharmacological and non-pharmacological interventions and research exploring the prevention of, and methods for identifying, sleep disturbance. Research mapping current practices and exploring families’ understanding of sleep disturbance and their experiences of obtaining help may facilitate service provision development.Study registrationThis study is registered as PROSPERO CRD42016034067.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Pharmacological interventions for COVID-19: Protocol for a Rapid Living Systematic Review with network meta-analysis

10.1101/2020.05.02.20088823 ◽

2020 ◽

Author(s):

Ana Carolina Pereira Nunes Pinto ◽

Aline Pereira da Rocha ◽

Keilla Martins Milby ◽

César Ramos Rocha-Filho ◽

Felipe Sebastião de Assis Reis ◽

...

Keyword(s):

Systematic Review ◽

Critical Appraisal ◽

Meta Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Pharmacological Interventions ◽

Systematic Review Methodology ◽

Assessment Development ◽

Randomized Controlled ◽

Central Register

ABSTRACTCONTEXT AND OBJECTIVECoronavirus disease 2019 (COVID-19) has emerged in China in December 2019 and rapidly spread. Although extraordinary efforts have been made on research regarding pharmacological interventions, none have proven effective. This is the protocol for a rapid living systematic review that aims to compare the effectiveness and safety of different pharmacological interventions for the treatment of COVID-19.METHODSrapid living systematic review methodology with Network Meta-Analysis following the recommendations of Cochrane Handbook. We will include randomized controlled trials (RCT) and quasi-RCTs that evaluate single and/or combined pharmacological interventions at any dose for the treatment of COVID-19. We will search PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), LILACS, Scopus and SciELO to identify potentially eligible studies. No language restrictions will be used in the selection. We will perform the critical appraisal of included studies with the Risk of Bias tool and the certainty of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE).

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What Have We Learned from Measuring Health-Related Quality of Life in Patients with Chronic Lymphocytic Leukemia? A Systematic Review of Published Studies from 1990 to 2007.

Blood ◽

10.1182/blood.v110.11.4718.4718 ◽

2007 ◽

Vol 110 (11) ◽

pp. 4718-4718

Author(s):

Stefano Molica ◽

Francesca Mauro ◽

Marco Vignetti ◽

Robin Foà ◽

Fabio Efficace

Keyword(s):

Quality Of Life ◽

Missing Data ◽

Lymphocytic Leukemia ◽

Controlled Trials ◽

Cochrane Central Register ◽

Health Related Quality ◽

Related Quality ◽

Health Related ◽

Robust Evidence

Abstract While a large amount of health-related quality of life (HRQOL) studies has been conducted in patients with solid tumors, no data are available for patients with CLL. The aim of the present work was therefore to quantify and evaluate the quality of studies investigating patient’s self-reported HRQOL in CLL patients. A systematic literature search for studies meeting the criteria, published from 1990 to 2007, was undertaken on a number of databases. Candidate articles were mainly searched in PubMed and the Cochrane Central Register of Controlled Trials (CENTRAL). Meeting abstracts at ASCO and ASH conferences were also assessed. We used the following key terms to identify candidate articles “quality of life” and “CLL” or “lymphocytic leukemia” or “chronic leukemia”. All articles included in the review were independently evaluated based on a pre-defined set of methodological issues and criteria by two reviewers (SM and FE). These included a number of methodological and statistical quality criteria such as HRQOL missing data documentation, timing of assessment, rationale for instrument selection and discussion of outcomes in terms of clinical significance. In addition, HRQOL and traditional clinical outcomes were extracted and analyzed. More than 200 candidate articles were evaluated, but only 5 studies met the inclusion criteria for the review. The majority of articles were excluded as HRQOL was not measured by patient’s reported tools. Overall, some 1019 patients were involved in these studies. HRQOL was assessed in 3 prospective randomized controlled trials (RCTs) and 2 longitudinal non-randomized studies. Two of these 5 studies were only published as abstracts. The EORTC QLQ-C30 was the most frequently used measure being utilized in 4 out of 5 studies. Some methodological constraints were identified, mainly in terms of handling of HRQOL missing data and possible lack of sensitivity of the measure being used. The most robust evidence stemmed from a prospective RCT comparing Fludarabine (F) vs. Fludarabine + Cyclophopsphamide (FC) where HRQOL was assessed as a secondary endpoint. While there was no significant HRQOL difference between treatment arms over time, this study showed nonetheless that the newer FC combination had no detrimental effect on patient’s HRQOL compared with the standard F arm. This information definitely reinforces concomitant clinical findings which favor the more intensive FC treatment (e.g. in terms of clinical response and progression-free survival). Taken together, very limited conclusions can to date be drawn with regard to HRQOL issues in patients with CLL in view of the paucity of data in this area. There is urgent need of implementing HRQOL research in patients with CLL and of providing the scientific community with robust evidence-based data on the impact of new treatment approaches in these patients.

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Surgical Interventions for the Treatment of Supracondylar Humerus Fractures in Children: Protocol of a Systematic Review (Preprint)

10.2196/preprints.8343 ◽

2017 ◽

Author(s):

Oreste Lemos Carrazzone ◽

João Carlos Belloti ◽

Fabio Teruo Matsunaga ◽

Nacime Salomão Barbachan Mansur ◽

Marcelo Hide Matsumoto ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Surgical Treatment ◽

Randomized Controlled Trials ◽

Outcome Data ◽

Risk Of Bias ◽

Controlled Trials ◽

Cochrane Central Register ◽

Surgical Interventions ◽

Randomized Controlled

BACKGROUND The treatment of supracondylar humerus fracture in children (SHFC) is associated with complications such as functional deficit, residual deformity, and iatrogenic neurological damage. The standard treatment is closed reduction and percutaneous Kirschner wire fixation with different configurations. Despite this fact, there is still no consensus on the most effective technique for the treatment of these fractures. OBJECTIVE The aim of this systematic review will be to evaluate the effect of surgical interventions on the treatment of Gartland type II and III SHFC by assessing function, complications, and error as primary outcomes. Clinical outcomes such as range of motion and pain and radiographic outcomes will also be judged. METHODS A systematic review of randomized controlled trials or quasi-randomized controlled trials evaluating the surgical treatment of SHFC will be carried out in the Cochrane Central Register of Controlled Trials, PubMed, Literatura Latino-Americana e do Caribe em Ciências da Saúde, and Excerpta Medica Database. The search will also occur at ongoing and recently completed clinical trials in selected databases. Data management and extraction will be performed using a data withdrawal form and by analyzing the following: study method characteristics, participant characteristics, intervention characteristics, results, methodological domains, and risk of bias. To assess the risk of bias of the included trials, the Cochrane Risk of Bias Tool will be used. Dichotomous outcome data will be analyzed as risk ratios, and continuous outcome data will be expressed as mean differences, both with 95% confidence intervals. Also, whenever possible, subgroup analysis, sensitivity analysis, and assessment of heterogeneity will be performed. RESULTS Following the publication of this protocol, searches will be run and included studies will be deeply analyzed. We hope to obtain final results in the next few months and have the final paper published by the end of 2018. This study was funded by a government-based noncommercial agency, Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP). CONCLUSIONS This study may provide surgical treatment effects evidence for SHFC. The results will assist clinical practice by demonstrating the effectiveness and potential complications of these interventions and might serve as a reference for future clinical trials on the topic. CLINICALTRIAL PROSPERO CRD42014009304; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=9304 (Archived by WebCite at http://www.webcitation.org/6usiDHzD7)

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Effective Parental intervention strategies to reduce screen time among preschool-aged children: A systematic review (Preprint)

10.2196/preprints.25774 ◽

2020 ◽

Author(s):

Diana Raj ◽

Halimatus Sakdiah Minhat ◽

Nor Afiah Mohd. Zulkefli ◽

Norliza Ahmad

Keyword(s):

Systematic Review ◽

Preschool Children ◽

Young Children ◽

Screen Time ◽

Mode Of Delivery ◽

Intervention Strategies ◽

Controlled Trials ◽

Cochrane Central Register ◽

Negative Consequences ◽

Parental Intervention

BACKGROUND The increasing screen time exposure among young children in general and the reported negative consequences associated with excessive ST, calls for focused strategies to reduce ST, especially among young children. OBJECTIVE This systematic review aimed to identify effective parental intervention strategies to reduce ST among preschool children. METHODS A total of five databases, namely Cochrane Central Register of Controlled Trials, CINAHL, Medline Complete, PubMed, and Scopus, were searched for randomised controlled trials that involved intervention strategies in ST reduction among preschool children. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines were used. RESULTS A total of nine studies were assessed. The results showed that besides providing knowledge and awareness regarding ST, having restrictive practices, offering alternative activities to parents, and removal of screen from child’s bedroom were the most common strategies used by studies that reported successful intervention. Intervention duration of between six to eight weeks was sufficient to produce ST reduction. Face-to-face method was the commonest mode of delivery. Theoretical constructs that aimed at increasing parental self-efficacy, listing outcome expectations, and offering reinforcement of strategies that targeted both the parents and home environment were beneficial in reducing ST. CONCLUSIONS By offering appropriate strategies to parents, a reduction in the amount of ST was observed among the children. Future intervention studies could benefit in exploring culturally adapted strategies, especially in developing countries. Trials of higher quality would also facilitate the drawing of conclusions in future research. CLINICALTRIAL PROSPERO No: CRD42020199398

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